Result of the Public Consultation on the Revision of the PIP Guideline Published

From January 2007 until March 2007, a public consultation was held on the revision of the so-called PIP Guideline ("Commission Guideline on the format and content of applications for agreement or modification of paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies", 2008/C 243/09). The European Commission launched this public consultation with the aim to develop the above-mentioned guideline, which was later published on 27 October 2008. Now the individual results of the public consultation and a summary have been published as well.

A total of 17 contributions were sent in, most of them showing a positive attitude to the guideline. Among the 3 authorities that have sent in their comments are the EMEA and the German Federal Institute for Drugs and Medical Devices (BfArM).

Nine pharmaceutical companies and representatives/associations of the pharmaceutical industry also commented on the proposed guideline. In general, most of the comments referred to the richness of detail. In this context, it is pointed out that, especially in early phases of clinical development, many pieces of information cannot yet be obtained.

The EMEA also handed in a comprehensive contribution. In principle, the EMEA welcomes the document, which it considers to be clear and understandable. However, the Agency does not support the requirement to have one PIP for several indications of a preparation during development. The EMEA would rather like to see a separate PIP created for each indication in order to facilitate the ensuing decisions. It also suggests that time spans within the framework of submissions be more exactly specified.

The individual contributions can be viewed here. The summary of the result can be found here.

Nevertheless, there are still uncertainties and ambiguities concerning this topic. For this reason, the EMEA published a revised Q&A document, which can be found under this link.

Author:Wolfgang SchmittOn behalf of the European Compliance Academy (ECA)

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